(1) A permitholder that has a facility used for the distribution or retailing of medical gases shall protect such gases from unauthorized access by implementing all of the following security measures:

(a) Keeping access from outside the premises well controlled and to a minimum.

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Terms Used In Florida Statutes 499.85

  • Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.82
  • distribution: means to sell; offer to sell; deliver; offer to deliver; transfer by either the passage of title, physical movement, or both; broker; or give away a medical gas. See Florida Statutes 499.82
  • Emergency use oxygen: means oxygen USP administered in emergency situations without a prescription for oxygen deficiency and resuscitation. See Florida Statutes 499.82
  • Federal act: means the Federal Food, Drug, and Cosmetic Act. See Florida Statutes 499.82
  • Medical oxygen: means oxygen USP which must be labeled in compliance with labeling requirements for oxygen under the federal act. See Florida Statutes 499.82
  • USP: means the United States Pharmacopeia. See Florida Statutes 499.82
  • Wholesale distribution: means the distribution of medical gas to a person other than a consumer or patient. See Florida Statutes 499.82
  • Wholesale distributor: means any person or entity engaged in wholesale distribution of medical gas within or into this state, including, but not limited to, manufacturers; own-label distributors; private-label distributors; warehouses, including manufacturers' and distributors' warehouses; and wholesale medical gas warehouses. See Florida Statutes 499.82
(b) Ensuring the outside perimeter of the premises is well lit.
(c) Limiting access into areas where medical gases are held to authorized personnel.
(d) Equipping all facilities with a fence or other system to detect or deter entry after hours.
(2) A facility used for distributing or retailing medical gases shall be equipped with a system that provides suitable protection against theft, including, if appropriate, protection against theft of computers or electronic records and the protection of the integrity and confidentiality of data and documents.
(3) A facility used for wholesale distribution of medical gases shall be equipped with inventory management and control systems that protect against, detect, and document any instances of theft of nitrous oxide.
(4) If a wholesale distributor uses electronic distribution records, the wholesale distributor shall employ, train, and document the training of personnel in the proper use of such technology and equipment.
(5) Vehicles used for on-call delivery of oxygen USP and oxygen-related equipment for home care use by home care providers may be parked at a place of residence and must be locked and equipped with an audible alarm when not attended.
(6) The department shall adopt rules that govern the distribution of medical oxygen for emergency use by persons authorized to receive emergency use oxygen. Unless the laws of this state specifically direct otherwise, such rules must be consistent with federal regulations, including the labeling requirements of oxygen under the federal act. Such rules may not be inconsistent with part III of chapter 401 or rules adopted thereunder.